According to the CDC, smoking is the leading cause of preventable death in the United States. The first published studies on the harmful effects of smoking on health were retrospective analysis of the smoking habits of patients suffering from lung cancer in 1950. Since, the major harmful effects attributed to smoking include but are not limited to heart disease, stroke, chronic obstructed pulmonary disease, and numerous cancers. While initially attributed to primary smoking activities, the harmful effects on the health of an individual extend to those exposed passively to tobacco smoke from the environment. These health consequences of tobacco use substantially increase the cost of healthcare. In 2014, the US Department of Health and Human Services issued a report titled “Health Consequences of Smoking—50 Years of Progress. A Report of the Surgeon General” estimating the economic costs resulting from lost productivity as a consequence from both early mortality and associated health care costs. Lost productivity across all demographics and disease states for adults 35 to 79 between the years 2005 and 2009 was estimated to be $151 billion. Aggregate health care expenditures attributable to cigarette smoking for adults 35 and older in 2012 alone was estimated to be $175.9 billion. Tobacco cessation initiatives have been created by both employer-based health care systems and public health systems to curb these economic losses and improve public health. However, monitoring for adherence to these cessation initiatives often relies on self-reporting. Literature reviews of the effectiveness of self-reporting screening for a wide variety of risk factors, including tobacco use, consistently finds significant under reporting, decreasing opportunities for interventions.
Tobacco exposure determination relies on the detection of substances directly or indirectly associated with the tobacco use. Tobacco contains numerous structurally similar alkaloids with the principle alkaloid, nicotine, making up about 95% of the total alkaloid content. Nicotine is the primary addictive substance in tobacco resulting in strong physical and psychological dependence, making nicotine replacement therapy (NRT) the leading choice in cessation activities, as it assists the individual to reduce nicotine intake without exposure to tobacco.
Current tests available for detection of tobacco are carbon monoxide, nicotine, and cotinine in varying matrices, such as urine, blood, breath, and/or saliva. However, plasma nicotine and carbon monoxide have short half-lives that may allow a person to stop smoking for a short time and test as a non-smoker. Cotinine, the major metabolite of nicotine, has been the metabolite of choice, as it the most abundant. It can be measured via a central lab in urine, saliva, or plasma. Point-of-care or near-patient setting is currently limited to qualitative tests from urine and saliva, complicating sampling collection and sample processing. However, objectively differentiating between active smokers and those who are trying to quit tobacco by using nicotine replacement therapy (NRT) is a current challenge.
Objectively detecting exposure to tobacco, eliminating the need for self-reporting, can be achieved by detecting substances directly absorbed by the body from tobacco or the metabolites and/or catabolites of these substances instead of the more traditional cotinine or nicotine, or carbon monoxide testing. Detectable tobacco alkaloids include nicotine, anabasine, and anatabine with numerous metabolites, only a few of which possess pharmacokinetics and pharmacokinetics characteristics that are desirable as indicators of tobacco exposure. The primary characteristics indicative of an effective indicator of tobacco exposure are long half-lives and overall abundance of the substance in the applicable matrix (i.e., urine, whole blood, plasma, saliva, etc.).
Thus, there is a need in the art to develop testing methods for the tobacco alkaloids cotinine, anabasine, anatabine, and/or myosamine to assess compliance for tobacco use status and compliance to tobacco cessation programs.